| Primary Device ID | 05414734309257 |
| NIH Device Record Key | cf71981c-65eb-4cbc-9d5e-e937593ea138 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | IBI-85942 |
| Catalog Number | IBI-85942 |
| Company DUNS | 926346966 |
| Company Name | IRVINE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Length | 2.5 Meter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry. Keep away from sunlight. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734309257 [Primary] |
| IKD | CABLE, ELECTRODE |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
[05414734309257]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-17 |
| Device Publish Date | 2025-12-09 |
| 05414734309257 - NA | 2025-12-171910-S Electrophysiology Cable |
| 05414734309257 - NA | 2025-12-17 1910-S Electrophysiology Cable |
| 05415067016669 - Cool Point™ | 2024-01-22 Pressure Alarm Adapter Cable |
| 05414734310659 - Therapy™ | 2020-05-01 Ablation Catheter |
| 05414734310666 - Therapy™ | 2020-05-01 Ablation Catheter |
| 05414734310680 - Therapy™ | 2020-05-01 Ablation Catheter |
| 05414734310734 - Safire™ Blu™ SP | 2020-05-01 Ablation Catheter |
| 05414734310741 - Safire™ Blu™ SP | 2020-05-01 Ablation Catheter |
| 05414734310765 - Safire™ Blu™ SP | 2020-05-01 Ablation Catheter |